Trial · NCT01300208
To Evaluate the Preliminary Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of CC-11050 in Subjects With Discoid Lupus Erythematosus and Subacute Cutaneous Lupus Erythematosus
NCT01300208, Phase 2, Completed, Amgen
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. To Evaluate the Preliminary Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of CC-11050 in Subjects With Discoid Lupus Erythematosus and Subacute Cutaneous Lupus Erythematosus. Trials, record NCT01300208. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01300208
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- To Evaluate the Preliminary Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of CC-11050 in Subjects With Discoid Lupus Erythematosus and Subacute Cutaneous Lupus Erythematosus
- NCT number
- NCT01300208
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 48 participants, actual
- Lead sponsor
- Amgen
- Conditions
- Cutaneous Lupus Erythematosus
- Interventions
- CC-11050, Placebo
- First posted
- 2011-02-21
- Last updated
- 2020-06-23
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Laboratory values from chemistry, hematology, urinalysis, inflammation/immunology panel that reveal clinically significant abnormalities and that may constitute a safety concern | Up to 21 weeks | |
| Secondary | Pharmacokinetics (PK) | Up to 21 weeks | To describe the area under the curve (AUC) of CC-11050 and M15 in plasma |
| Secondary | To assess the clinical response rate of CC-11050 in subjects with discoid lupus erythematosus or sub acute lupus erythematosus using the Cutaneous Lupus Area and Severity Index Activity Score following 12-weeks of treatment | 12 weeks | |
| Secondary | Pharmacokinetics (PK) | Up to 21 weeks | To describe the peak serum concentration (Cmax) of CC-11050 and M15 in plasma |
| Secondary | Pharmacokinetics | Up to 21 weeks | To describe the lowest serum concentration (Cmin)of CC-11050 and M15 in plasma |
| Secondary | Pharmacokinetics (PK) | Up to 21 weeks | To describe the time after administration of a drug when the maxiumum plasma concentration is reached (tmax) of CC-11050 and M15 in plasma |
| Secondary | Pharmacokinetics (PK) | Up to 21 weeks | To describe the half life (t1/2) of CC-11050 and M15 in plasma |
| Secondary | Pharmacokinetics (PK) | Up to 21 weeks | To describe the oral clearance (CL/F) of CC-11050 and M15 in plasma |
| Secondary | Pharmacokinetics (PK) | Up to 21 weeks | To describe the volume of distribution (Vz/F) of CC-11050 and M15 in plasma |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01300208
GET https://conductscience.org/api/trials/v1/NCT01300208/registered